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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K031728
Device Name KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
Applicant
Klimamed Technologie Medizingerate GmbH
1380 Lead Hill Blvd.
Suite 106
Roseville,  CA  95661
Correspondent
Klimamed Technologie Medizingerate GmbH
1380 Lead Hill Blvd.
Suite 106
Roseville,  CA  95661
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/04/2003
Decision Date 10/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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